Management Forum Logo

Presented by
Management Forum

Variations to Marketing Authorisations Training Course

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

★★★★★ "Excellent webinar! [Speaker is] engaging and friendly."

13-14 Oct 2022

Need help?  Enrol or reserve

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

It is a key post-marketing responsibility of the marketing authorisation holder (MAH) to keep dossiers up to date, and changes must be submitted as variations to the appropriate regulatory authority.

This interactive event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval. The programme will include filing tips and strategies with information and advice on creating a global dossier and implementation periods.

Practical sessions throughout the two days will provide an opportunity to discuss different scenarios and strategies with other participants.

Benefits of attending:

  • Gain an overview of the EU system for variations
  • Assess how pharma companies are working in this evolving regulatory environment
  • Profit from practical advice on the preparation and submission of variation applications
  • Understand the impact of Module 3 on your variations dossier
  • Discuss filing tips and strategies to help achieve faster approval

Who should attend?

This course will be particularly relevant for those working in registration and regulatory affairs. It will also be of interest to anyone with an involvement in the variations process including QA, clinical safety and pharmacovigilance personnel.

Enrol or reserve

The Variations to Marketing Authorisations course will cover:

Pharmaceutical Medicine and Documentation

  • The role of regulatory affairs
  • The structure of the Common Technical Document (CTD)
  • Reasons for change

Legislation & Guidance (incl. Case Studies)

  • Regulation 1234/2008 and 712/2012 explained
  • Guideline classifications

Introduction to Variations

  • Variation Type IA (IN), Type IB and Type II
    • EU variation classification guideline
  • Line extensions
  • Renewals

Variations in Detail

  • Timelines of variations
  • Grouping and work-sharing
  • The impact on SmPC, labelling and/or product information (PI)

A Closer Look at Module 3

  • Structure of module 3
    • Potential scenario’s
  • The Quality Target Product Profile (QTPP)
  • Quality by Design (QbD)

ICH Q12

  • An overview of ICH Q12

Global Variations

  • US, Canada, Australia variations
  • Global variation planning

Global Variation Planning

Case study

The Importance of Lean and Structured Authoring

Trends and Developments

  • Evolving landscape towards structured data
    • Identification of Medicinal Products (IDMP)
    • Digital Application Dataset Integration (DADI)
    • Pharmaceutical Quality – Chemistry, Manufacturing and Control (PQ-CMC)
    • FDA KASA
    • Accumulus Synergy
  • ICH M4Q revision
  • New manufacturing technologies
  • EU pharma revision
  • Reliance pathways

Enrol or reserve

Marloes van der Geer

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

More details

Joanne Roza

Joanne Roza works as a senior regulatory affairs consultant at Qdossier. She is involved in regulatory affairs consultancy and has also expertise in regulatory operations for big- and small-sized pharmaceutical companies. Joanne holds a bachelor degree in Health Sciences from Maastricht University and a master degree in Health Economics, Policy and Law from the Erasmus University in Rotterdam. She started her career at Qdossier in 2016 and has been involved in a variety of regulatory operations and affairs projects. Joanne’s areas of expertise are: regulatory affairs (strategy and planning), preparation/creation and dispatch of different types of electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring and the creation of baseline (CMC) submissions.





More details

Book Variations to Marketing Authorisations Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

13-14 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11721

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

Limited places remaining

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Variations to Marketing Authorisations training course


Excellent webinar! [Speaker is] engaging and friendly.

Apr 13 2021

Abhijit Nair
Regulatory Affairs Officer, Consilient health

Apr 13 2021

It was very interesting and informative.

Dubravka Božičević
Senior Advisor for Validation of Applications, Cratian Agency for medicinal products and medical devices - HALMED

Oct 8 2020

Excellent, clear and interactive

Mohit Pandey
Morningside Healthcare Limited

Oct 8 2020

Andrew is a good speaker and managed to keep our attention during these two days despite the fact that it was a webinar.

Chloë Braud
International Regulatory Affairs Pharmacist, Guerbet

United Kingdom

  • 3M Healthcare Ltd
  • Abbott Laboratories Ltd
  • Allergan UK Limited
  • Allergy Therapeutics Ltd
  • Alliance Pharmaceuticals Ltd
  • Almac Group
  • Archimedes Pharma Ltd
  • Archimedes Pharma UK Limited
  • Avon Automotive plc
  • Bayer Healthcare
  • BlueReg Pharma Consulting
  • BOC Ltd (part of the Linde Group)
  • Boehringer Ingelheim Ltd
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd
  • Chemidex Pharma Ltd
  • Chiesi Limited
  • Co-Operative Pharmacy
  • Consilient health
  • Cross Vetpharm Group UK LTD
  • Cyton Biosciences Ltd
  • Dechra Ltd
  • E.C. De Witt & Company Limited
  • Eli Lilly & Co Ltd
  • Fresenius Kabi Ltd
  • Fresenius Kabi UK Ltd
  • Galderma (UK) Limited
  • Galen Ltd
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Ipsen Biopharm Ltd
  • Janssen-Cilag Ltd
  • JensonR+ Ltd
  • Karib Kemi Pharm Ltd
  • Lundbeck Limited
  • Martindale
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mentholatum Co Ltd
  • Milpharm Ltd/Aurobindo Pharma Limited
  • Morningside Healthcare Limited
  • Mylan
  • NAPP PHARMACEUTICALS
  • NDA Regulatory Science Ltd
  • Novartis Pharmaceuticals UK Ltd
  • Pierre Fabre Ltd
  • Procter & Gamble Technical Centres Ltd
  • Ranbaxy Laboratories Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Limited
  • S A Consultancy Ltd
  • Sanofi Pasteur MSD Ltd
  • Shire Pharmaceutical Ltd
  • SHORE LTD
  • Sinclair IS Pharmaceuticals Ltd
  • Teva Pharmaceuticals Europe B.V.
  • Teva UK Ltd
  • Torbay Pharmaceuticals
  • UCB Celltech
  • Waymade Plc
  • Winthrop Pharmaceuticals UK Ltd
  • Wrafton Laboratories Ltd, t/a Perrigo

Belgium

  • GRUNENTHAL NV
  • Janssen Pharmaceutica NV
  • PHARA Plus Life Science Services BVBA
  • SCHERING-PLOUGH LABO NV

France

  • Galderma International
  • Guerbet
  • HRA Pharma Rare Diseases
  • Sanofi Pasteur MSD

Netherlands

  • Abbott Healthcare Products BV
  • Intervet Nederland bv
  • Leyden Delta bv
  • Viatris

Switzerland

  • Novartis International AG
  • Novartis Vaccines & Diagnostics AG
  • ObsEva

Croatia

  • Cratian Agency for medicinal products and medical devices - HALMED
  • Novartis Hrvatska doo

Czech Republic

  • Zentiva Group AS
  • Zentiva ks

Denmark

  • Atnahs Pharma Nordics
  • Novo Nordisk A/S

Ireland

  • Irish Patents Office
  • Labopharm Europe Ltd

Israel

  • Blau Pharmaceutical Services
  • Perrigo Israel Pharmaceuticals Ltd

Austria

  • EVER Valinject GmbH

Germany

  • Life Molecular Imaging

Italy

  • SIFI S.p.A.

Malta

  • APL Swift Services (Malta) Ltd

Portugal

  • Bluepharma - Indústria Farmacêutica, SA - VAT PT505282801

Slovak Republic

  • Ewopharma International, s.r.o.

Spain

  • Casen Recordati SL

Sweden

  • Fresenius Kabi AB

Enrol or reserve

Run Variations to Marketing Authorisations Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy